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Guangzhou Fortunique , Ltd.
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GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS is an FDA 510(k)-cleared medical device (K041501) manufactured by Guangzhou Fortunique , Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 29, 2004. Regulation: 8.